Drafts of ICH Q2(R2) and Q14 on Public Consultation

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Draft versions of the revision of ICH Q2, Validation of Analytical Procedures, and also the new guideline Q14, Analytical Procedure Development, were published on the 24th March 2022. The deadline for comments is 31st July 2022.

You can view the draft guidelines, and also a presentation from ICH about the guidelines, using the following links:

ICH Q2(R2)
ICH Q14
Presentation
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Services related to this content that we offer

The current version of the ICH guidance, R1, and the proposed updates in the draft of R2, are comprehensively covered in our courses, ‘Validation, Verification and Transfer of Methods for Pharmaceutical Analysis‘and ‘Validation, Verification and Transfer of Methods for Biopharmaceutical Analysis‘.

Visit our courses page for a full list of available courses and the schedule of currently available course dates.